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Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer

Phase 3
18 Years
Not Enrolling
Bladder Cancer

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Trial Information

Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer


- Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at
risk of recurrent superficial bladder cancer after complete resection of initial tumor.

- Determine the treatment effects in modulating the expression of retinoid receptors,
chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy),
apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of
recurrent disease) in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.

Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28
days for up to 1 year in the absence of disease progression, unacceptable toxicity, or
development of a second primary cancer requiring therapy.

Patients are followed every 3 months for 15 months.

PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.

Inclusion Criteria


- Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2)
transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria:

- Newly diagnosed and no more than 4 weeks since resection

- Secondary after being tumor free (including carcinoma in situ) for more than 12
months with no intravesical therapy within that 12 months OR

- Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with
Bacillus Calmette-Guerin (BCG).

- Must have received 6 weeks of induction BCG followed by no evidence of disease
by cystoscopy and cytology and then further treatment with 3 weekly doses of

- Visible tumor totally resected within 4 weeks prior to study entry and no further
surgery, intravesical therapy, or systemic therapy planned

- No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor
at resection

- No metastatic disease



- 18 and over

Performance status:

- Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2

Life expectancy:

- At least 2 years


- white blood count (WBC) greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 11.0 g/dL


- serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase
(SGPT) less than 1.5 times upper limit of normal (ULN)


- Creatinine less than 2.0 mg/dL


- Triglyceride level less than 2.5 times ULN

- No other concurrent malignancy except nonmelanomatous skin cancer

- No other malignancy within the past 5 years unless currently disease free, at least 6
months since prior therapy, no current or planned active therapy, and expected
disease-free survival at least 2 years

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after the
study participation


Biologic therapy:

- See Disease Characteristics

- No concurrent systemic biologic therapy


- See Disease Characteristics

- No prior systemic cytotoxic chemotherapy for bladder cancer

- At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer

- No concurrent systemic chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy to the bladder

- No concurrent radiotherapy


- See Disease Characteristics


- At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta
carotene (at least 30 mg/day)

- At least 3 months since prior retinoid therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Recurrence rate of transitional cell carcinoma (TCC)

Outcome Description:

Recurrence rates is defined as proportion of participants who recur within one year of surgery.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Anita L. Sabichi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

March 2005

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms



Baylor College of Medicine Houston, Texas  77030
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108